Worth a look at the following article excerpts posted this morning.
Pointer Link provided:
Congressional Fact-finding on Follow-on Biologics: Patent Issues
See full article: http://www.patentdocs.net/patent_docs/2008/08/congressio=
nal-f.html
August 13, 2008
Kevin Noonan at Patent Docs will be posting a follow-up to some highly inte=
resting questions.
3. Please explain if patents on biotech medicines will provide meaningful =
protection of intellectual property if a pathway is created to allow for th=
e regulatory approval of FOBs? How do patents on biotechnological medicine=
s compare or differ in the value they offer to traditional small-molecule d=
rugs, if an FOB'S pathway requires only that the FOB be highly similar to t=
he reference product?4. What procedures, if any, should be included in leg=
islation to enable reference product companies or third parties to identify=
potential patent infringement claims by a biosimilar company and to ensure=
timely resolution of legal disputes?5. If patent issues are to be address=
ed in a statute, how should we balance the interests of third-party patent =
holders and the reference product sponsor?6. Should an FOB statute require=
FDA to administer patent listing and notification provisions as Hatch-Waxm=
an does?
Comments/Questions on European model:
European Model (abbreviated approval pathway):
1. The European Union (EU) regulatory system for biosimilars requires the =
development of product-specific guidances which detail the standard for app=
roval that would need to be met by a biosimilar in a defined product class.=
Do you think these guidances would provide similar benefits to industry, =
healthcare providers, and patients in the U.S.?
2. Legislation passed by the European Parliament encourages innovation by =
providing 10 years of market exclusivity, extendable to 11 years for select=
new indications of use, for innovator biologics, thereby preventing the in=
troduction of FOBs during that period. Should the U.S. be guided by treatm=
ent of drugs and biologics in the EU with respect to exclusivity periods?
Sherri Voebel
Corporate Patents
1329 Danada Court
Naperville, IL 60053
630-710-1004
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Received on Thu Aug 14 2008 - 16:39:32
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